PlainRecalls

2019 Recall Year Insight

Federal agencies issued 7,611 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 7.29% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 20.9 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 153 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2019.

On this page of 50 records, severity classification shows 17 critical, 33 moderate, and 0 lower-severity recalls. The page references 12 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (25), FDA Devices (25), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2019 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Oct 9, 2019

L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

FDA Drug Moderate Oct 9, 2019

LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315

KRS Global Biotechnology, Inc

FDA Drug Moderate Oct 9, 2019

Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10

Torrent Pharma Inc.

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Paltop Advanced Dental Solutions Ltd

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350

Inter-Med Llc

FDA Devices Moderate Oct 9, 2019

Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Voco GmbH

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

Quality Electrodynamics LLC

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

Baxter Healthcare Corporation

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the bo

Roche Diabetes Care, Inc.

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

The Metrix Company

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use

Medtronic Vascular

FDA Devices Moderate Oct 9, 2019

C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Stryker Instruments Div. of Stryker Corporation

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use

Medtronic Vascular

FDA Devices Critical Oct 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use

Medtronic Vascular

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2019 with 2018 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2019

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2019 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.